Systems of Support Study for Childhood Depression (SOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Boston University
Sponsor:
Collaborators:
University of California, Los Angeles
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01159041
First received: July 7, 2010
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

This study is designed to compare two treatments for depression in pre-adolescent (7-13 year old) children. A family-focused treatment will be compared to an individual child-focused treatment in this 14-week intervention.


Condition Intervention Phase
Depression
Behavioral: Family Focused Treatment (FFT)
Behavioral: Individual Treatment (IP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Family Focused Treatment for Childhood Depression

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Improvement in Depressive Disorder [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in Depressive Symptoms [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Depressive symptoms as rated by a trained assessor.


Secondary Outcome Measures:
  • Child-reported Depressive Symptoms [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Parent Report of Associated Symptoms [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Child's Social Functioning [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Focused Treatment (FFT) Behavioral: Family Focused Treatment (FFT)
FFT is designed to specifically address the developmental needs of school-aged children and their parents through an emphasis on fostering positive and supportive parent-child interactions that scaffold the development of a positive self, to help parents provide the child additional positive feedback on his/her developmentally appropriate achievements, and to enhance family and child coping. This treatment is conducted with the child and his/her parent(s) and includes education about depression, communication training, relationship enhancement, and problem-solving.
Active Comparator: Individual Treatment (IP) Behavioral: Individual Treatment (IP)
The goals of the treatment are to foster the therapeutic relationship, to provide a supportive and empathic setting where the child can come to better understand his/her emotions/feelings and address issues underlying current symptoms. Therapeutic goals will be addressed through reflection and clarification of feelings/emotions and understanding the child's perception of the context of depressed feelings.

Detailed Description:

Childhood-onset depression is an impairing and often recurrent and persistent disorder that impacts current and later development resulting in high personal, social, and economic costs. Despite the costs of early-onset depression, the emphasis in current practice parameters on an initial course of psychosocial treatment, and extensive research on adolescent depression, we currently lack randomized controlled trials evaluating psychosocial treatments for children with depressive disorders.

The present proposal aims to address this gap in knowledge regarding optimal psychosocial treatment strategies for children suffering from depressive disorders. We propose a 2-site randomized controlled trial to evaluate the efficacy of Family Focused Treatment (FFT), as compared to an individual client-centered psychotherapy (IP) modeled after "usual" community care. FFT adopts an interpersonal model for understanding how depressive symptoms are maintained, emphasizes developing family skills/strategies for altering interpersonal processes, and works on building a family environment that supports recovery and enhances stress resistance and resilience. This approach may be particularly appropriate to the developmental needs of depressed children, given their dependence on parents, the potential of FFT to address the needs of multiple family members, and our data supporting benefits on depression, functioning, and other co-occurring symptoms.

The proposed project will enroll 140 children (ages 8-12) with depressive disorders. Children will be randomly assigned to receive a 14-week trial of either FFT or IP. At study entry, immediately post-treatment, and at a 9-month post-treatment follow-up all participants will undergo intensive evaluation of clinical state and psychosocial and family functioning.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current Depressive Disorder
  • ages 7-13 years
  • living with at least one biological parent willing to participate

Exclusion Criteria:

  • thought disturbance
  • severe conduct disorders
  • unstable on antidepressant medications
  • continuation in current non-study treatment
  • non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159041

Locations
United States, California
UCLA Semel Institute for Neuroscience and Human Behavior Recruiting
Los Angeles, California, United States, 90095
Contact: Joan R. Asarnow, Ph.D.    310-794-4962      
Principal Investigator: Joan R. Asarnow, Ph.D.         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Martha C. Tompson, Ph.D.    617-358-4584    families@bu.edu   
Principal Investigator: Martha C. Tompson, Ph.D.         
Sponsors and Collaborators
Boston University
University of California, Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Martha C. Tompson, Ph.D., Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT01159041     History of Changes
Other Study ID Numbers: 1R01MH082861, R01MH082856-01A2, R01MH082861-01A2
Study First Received: July 7, 2010
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Depression, children, adolescent, family

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014